ID

39607

Descripción

A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract; ODM derived from: https://clinicaltrials.gov/show/NCT01697800

Link

https://clinicaltrials.gov/show/NCT01697800

Palabras clave

Versiones (1)
  1. 3/2/20 3/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de febrero de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT01697800

Inglés

Eligibility Head and Neck Squamous Cell Carcinoma NCT01697800

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥21 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma or histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence). patients may have local stage i or ii, or locoregionally advanced hnscc stage iii or iv of the oral cavity, oropharynx, larynx, hypopharynx, or unknown primary, but no metastatic disease; intent to treat with primary radiotherapy +/-chemotherapy
Descripción

Squamous cell carcinoma of the head and neck Invasive Untreated Disease length | Recurrent Head and Neck Squamous Cell Carcinoma Untreated Disease length | Treatment completed Primary disorder | Recurrence Last | Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of mouth Advanced TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of oropharynx Advanced TNM clinical staging | Laryngeal Squamous Cell Carcinoma TNM clinical staging | Laryngeal Squamous Cell Carcinoma Advanced TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx Advanced TNM clinical staging | Squamous cell carcinoma of unknown primary TNM clinical staging | Squamous cell carcinoma of unknown primary Advanced TNM clinical staging | Neoplasm Metastasis Absent | Therapeutic radiology procedure | Chemotherapy | Chemotherapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0332155
UMLS CUI [1,4]
C0872146
UMLS CUI [2,1]
C4524839
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0872146
UMLS CUI [3,1]
C0580352
UMLS CUI [3,2]
C0277554
UMLS CUI [4,1]
C2825055
UMLS CUI [4,2]
C1517741
UMLS CUI [5,1]
C0585362
UMLS CUI [5,2]
C3258246
UMLS CUI [6,1]
C0585362
UMLS CUI [6,2]
C0205179
UMLS CUI [6,3]
C3258246
UMLS CUI [7,1]
C0280313
UMLS CUI [7,2]
C3258246
UMLS CUI [8,1]
C0280313
UMLS CUI [8,2]
C0205179
UMLS CUI [8,3]
C3258246
UMLS CUI [9,1]
C0280324
UMLS CUI [9,2]
C3258246
UMLS CUI [10,1]
C0280324
UMLS CUI [10,2]
C0205179
UMLS CUI [10,3]
C3258246
UMLS CUI [11,1]
C0280321
UMLS CUI [11,2]
C3258246
UMLS CUI [12,1]
C0280321
UMLS CUI [12,2]
C0205179
UMLS CUI [12,3]
C3258246
UMLS CUI [13,1]
C0280097
UMLS CUI [13,2]
C3258246
UMLS CUI [14,1]
C0280097
UMLS CUI [14,2]
C0205179
UMLS CUI [14,3]
C3258246
UMLS CUI [15,1]
C0027627
UMLS CUI [15,2]
C0332197
UMLS CUI [16]
C1522449
UMLS CUI [17]
C0392920
UMLS CUI [18,1]
C0392920
UMLS CUI [18,2]
C0332197
3. disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
Descripción

Disease Amenable Biopsy | Outpatient | Biopsy Routine Clinic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
UMLS CUI [2]
C0029921
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C1547137
UMLS CUI [3,3]
C0442592
4. ecog performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
5. required laboratory data (to be obtained within 2 weeks of initiation):
Descripción

Obtain laboratory data Required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677148
UMLS CUI [1,2]
C1514873
platelets > 75,000/mm³
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
calculated creatinine clearance (crcl)> 60 ml/min
Descripción

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711451
total serum bilirubin < 1.5 mg/dl
Descripción

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
6. willingness and ability to give signed written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. medical contraindication to biopsy of target lesion
Descripción

Medical contraindication Biopsy Target Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C2986546
2. intercurrent illness likely to prevent protocol therapy or conventional planned therapy
Descripción

Comorbidity Preventing Treatment Protocol | Comorbidity Preventing Conventional Treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0040808
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2945704
3. prior daily use of tadalafil or other long-acting pde5 inhibitors for one month or greater
Descripción

tadalafil | Phosphodiesterase 5 inhibitor Active Long-term

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1176316
UMLS CUI [2,1]
C1318700
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0443252
4. known severe hypersensitivity to tadalafil or any of the excipients of this product
Descripción

Severe allergy Tadalafil | Severe allergy Tadalafil Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C1176316
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C1176316
UMLS CUI [2,3]
C0015237
5. current treatment with nitrates
Descripción

Nitrates

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0028125
6. current systemic treatment with a potent cytochrome p450 3a4 (cyp3a4) inhibitor such as ketoconazole or ritonavir
Descripción

Systemic therapy | CYP3A4 Inhibitor Strong | Ketoconazole | Ritonavir

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2,1]
C3830624
UMLS CUI [2,2]
C0442821
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0292818
7. history of hypotension and/or blindness during prior treatment with tadalafil or other pde-5 inhibitors
Descripción

Hypotension | Blindness | Relationship Prior Therapy | tadalafil | Phosphodiesterase 5 inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0456909
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C1514463
UMLS CUI [4]
C1176316
UMLS CUI [5]
C1318700
8. prior history of non-arterial ischemic optic retinopathy
Descripción

Retinal Disease Ischemic | Involvement Arterial Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0475224
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0221464
UMLS CUI [2,3]
C0332197
9. prior adverse reaction to diphtheria vaccine
Descripción

Diphtheria vaccines allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571552
10. pregnant or breastfeeding; a negative pregnancy test is required within 14 days of randomization for all women of childbearing potential.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
11. concurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer), for which the survival prognosis is < 5 years
Descripción

Curative treatment Cancer Other | Curative treatment Malignant Neoplasm Previous | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Cervix carcinoma | Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0302592
UMLS CUI [6]
C0023671
12. treatment with a non-approved or investigational drug within 30 days before visit 1
Descripción

Drugs, Non-Prescription | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
13. incomplete healing from previous oncologic or other major surgery
Descripción

Healing Incomplete Surgery Oncologic | Healing Incomplete Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0205257
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0205478
UMLS CUI [2,1]
C0043240
UMLS CUI [2,2]
C0205257
UMLS CUI [2,3]
C0679637
14. as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Descripción

Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0035204
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0035204
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0018799
UMLS CUI [8,2]
C0205433
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0205433
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205433
15. evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
Descripción

Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
16. history of significant hypotensive episode requiring hospitalization
Descripción

Hypotensive episode Hospitalization Required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0520541
UMLS CUI [1,2]
C1708385
17. history of acute myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure
Descripción

Myocardial Infarction | Angina Pectoris Uncontrolled | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0205318
18. history of any of the following cardiac conditions:
Descripción

Heart condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3842523
i. angina requiring treatment with long-acting nitrates ii. angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration iii. unstable angina within 90 days of visit 1 (braunwald 1989) iv. positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
Descripción

Angina Pectoris | Requirement Nitrates Active Long-term | Requirement Nitrates Active short-term | Angina, Unstable | Cardiac stress test normal | Interventional procedure cardiac absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0028125
UMLS CUI [2,3]
C0205177
UMLS CUI [2,4]
C0443252
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0028125
UMLS CUI [3,3]
C0205177
UMLS CUI [3,4]
C0443303
UMLS CUI [4]
C0002965
UMLS CUI [5]
C1096370
UMLS CUI [6,1]
C0184661
UMLS CUI [6,2]
C0018787
UMLS CUI [6,3]
C0332197
19. history of any of the following coronary conditions within 90 days of planned tadalafil administration:
Descripción

Condition Coronary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1522318
i. myocardial infarction ii. coronary artery bypass graft surgery iii. percutaneous coronary intervention (for example, angioplasty or stent placement) iv. any evidence of heart disease (nyha≥class iii as defined in protocol attachment lvhg.3) within 6 months of planned tadalafil administration
Descripción

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angioplasty | Placement of stent | Heart Disease New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0162577
UMLS CUI [5]
C0522776
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C1275491
20. prior chronic immune suppressive state (aids, immunosuppressive therapy)
Descripción

Immunosuppression chronic | AIDS | Therapeutic immunosuppression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0001175
UMLS CUI [3]
C0021079
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT01697800

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥21 years
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck Invasive Untreated Disease length | Recurrent Head and Neck Squamous Cell Carcinoma Untreated Disease length | Treatment completed Primary disorder | Recurrence Last | Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of mouth Advanced TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of oropharynx Advanced TNM clinical staging | Laryngeal Squamous Cell Carcinoma TNM clinical staging | Laryngeal Squamous Cell Carcinoma Advanced TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx Advanced TNM clinical staging | Squamous cell carcinoma of unknown primary TNM clinical staging | Squamous cell carcinoma of unknown primary Advanced TNM clinical staging | Neoplasm Metastasis Absent | Therapeutic radiology procedure | Chemotherapy | Chemotherapy Absent
Item
2. histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma or histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence). patients may have local stage i or ii, or locoregionally advanced hnscc stage iii or iv of the oral cavity, oropharynx, larynx, hypopharynx, or unknown primary, but no metastatic disease; intent to treat with primary radiotherapy +/-chemotherapy
boolean
C1168401 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0872146 (UMLS CUI [1,4])
C4524839 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0872146 (UMLS CUI [2,3])
C0580352 (UMLS CUI [3,1])
C0277554 (UMLS CUI [3,2])
C2825055 (UMLS CUI [4,1])
C1517741 (UMLS CUI [4,2])
C0585362 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
C0585362 (UMLS CUI [6,1])
C0205179 (UMLS CUI [6,2])
C3258246 (UMLS CUI [6,3])
C0280313 (UMLS CUI [7,1])
C3258246 (UMLS CUI [7,2])
C0280313 (UMLS CUI [8,1])
C0205179 (UMLS CUI [8,2])
C3258246 (UMLS CUI [8,3])
C0280324 (UMLS CUI [9,1])
C3258246 (UMLS CUI [9,2])
C0280324 (UMLS CUI [10,1])
C0205179 (UMLS CUI [10,2])
C3258246 (UMLS CUI [10,3])
C0280321 (UMLS CUI [11,1])
C3258246 (UMLS CUI [11,2])
C0280321 (UMLS CUI [12,1])
C0205179 (UMLS CUI [12,2])
C3258246 (UMLS CUI [12,3])
C0280097 (UMLS CUI [13,1])
C3258246 (UMLS CUI [13,2])
C0280097 (UMLS CUI [14,1])
C0205179 (UMLS CUI [14,2])
C3258246 (UMLS CUI [14,3])
C0027627 (UMLS CUI [15,1])
C0332197 (UMLS CUI [15,2])
C1522449 (UMLS CUI [16])
C0392920 (UMLS CUI [17])
C0392920 (UMLS CUI [18,1])
C0332197 (UMLS CUI [18,2])
Disease Amenable Biopsy | Outpatient | Biopsy Routine Clinic
Item
3. disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
boolean
C0012634 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0029921 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C1547137 (UMLS CUI [3,2])
C0442592 (UMLS CUI [3,3])
ECOG performance status
Item
4. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Obtain laboratory data Required
Item
5. required laboratory data (to be obtained within 2 weeks of initiation):
boolean
C0677148 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelets > 75,000/mm³
boolean
C0032181 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance (crcl)> 60 ml/min
boolean
C2711451 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total serum bilirubin < 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Informed Consent
Item
6. willingness and ability to give signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Biopsy Target Lesion
Item
1. medical contraindication to biopsy of target lesion
boolean
C1301624 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
Comorbidity Preventing Treatment Protocol | Comorbidity Preventing Conventional Treatment
Item
2. intercurrent illness likely to prevent protocol therapy or conventional planned therapy
boolean
C0009488 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2945704 (UMLS CUI [2,3])
tadalafil | Phosphodiesterase 5 inhibitor Active Long-term
Item
3. prior daily use of tadalafil or other long-acting pde5 inhibitors for one month or greater
boolean
C1176316 (UMLS CUI [1])
C1318700 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
Severe allergy Tadalafil | Severe allergy Tadalafil Excipient
Item
4. known severe hypersensitivity to tadalafil or any of the excipients of this product
boolean
C2945656 (UMLS CUI [1,1])
C1176316 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C1176316 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Nitrates
Item
5. current treatment with nitrates
boolean
C0028125 (UMLS CUI [1])
Systemic therapy | CYP3A4 Inhibitor Strong | Ketoconazole | Ritonavir
Item
6. current systemic treatment with a potent cytochrome p450 3a4 (cyp3a4) inhibitor such as ketoconazole or ritonavir
boolean
C1515119 (UMLS CUI [1])
C3830624 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0022625 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
Hypotension | Blindness | Relationship Prior Therapy | tadalafil | Phosphodiesterase 5 inhibitor
Item
7. history of hypotension and/or blindness during prior treatment with tadalafil or other pde-5 inhibitors
boolean
C0020649 (UMLS CUI [1])
C0456909 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1176316 (UMLS CUI [4])
C1318700 (UMLS CUI [5])
Retinal Disease Ischemic | Involvement Arterial Absent
Item
8. prior history of non-arterial ischemic optic retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0221464 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Diphtheria vaccines allergy
Item
9. prior adverse reaction to diphtheria vaccine
boolean
C0571552 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative
Item
10. pregnant or breastfeeding; a negative pregnancy test is required within 14 days of randomization for all women of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Curative treatment Cancer Other | Curative treatment Malignant Neoplasm Previous | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Cervix carcinoma | Life Expectancy
Item
11. concurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer), for which the survival prognosis is < 5 years
boolean
C1273390 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
C0023671 (UMLS CUI [6])
Drugs, Non-Prescription | Investigational New Drugs
Item
12. treatment with a non-approved or investigational drug within 30 days before visit 1
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Healing Incomplete Surgery Oncologic | Healing Incomplete Major surgery
Item
13. incomplete healing from previous oncologic or other major surgery
boolean
C0043240 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0205478 (UMLS CUI [1,4])
C0043240 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C0679637 (UMLS CUI [2,3])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated
Item
14. as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0018799 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205433 (UMLS CUI [10,2])
Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
15. evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Hypotensive episode Hospitalization Required
Item
16. history of significant hypotensive episode requiring hospitalization
boolean
C0520541 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Myocardial Infarction | Angina Pectoris Uncontrolled | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled
Item
17. history of acute myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Heart condition
Item
18. history of any of the following cardiac conditions:
boolean
C3842523 (UMLS CUI [1])
Angina Pectoris | Requirement Nitrates Active Long-term | Requirement Nitrates Active short-term | Angina, Unstable | Cardiac stress test normal | Interventional procedure cardiac absent
Item
i. angina requiring treatment with long-acting nitrates ii. angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration iii. unstable angina within 90 days of visit 1 (braunwald 1989) iv. positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
boolean
C0002962 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C0205177 (UMLS CUI [2,3])
C0443252 (UMLS CUI [2,4])
C1514873 (UMLS CUI [3,1])
C0028125 (UMLS CUI [3,2])
C0205177 (UMLS CUI [3,3])
C0443303 (UMLS CUI [3,4])
C0002965 (UMLS CUI [4])
C1096370 (UMLS CUI [5])
C0184661 (UMLS CUI [6,1])
C0018787 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Condition Coronary
Item
19. history of any of the following coronary conditions within 90 days of planned tadalafil administration:
boolean
C0348080 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angioplasty | Placement of stent | Heart Disease New York Heart Association Classification
Item
i. myocardial infarction ii. coronary artery bypass graft surgery iii. percutaneous coronary intervention (for example, angioplasty or stent placement) iv. any evidence of heart disease (nyha≥class iii as defined in protocol attachment lvhg.3) within 6 months of planned tadalafil administration
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0162577 (UMLS CUI [4])
C0522776 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
Immunosuppression chronic | AIDS | Therapeutic immunosuppression
Item
20. prior chronic immune suppressive state (aids, immunosuppressive therapy)
boolean
C4048329 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001175 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
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